Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT01887158
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2013-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D001726', 'term': 'Bisacodyl'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-15', 'studyFirstSubmitDate': '2013-06-11', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of bowel preparation rated according to a modified Ottawa bowel preparation scale', 'timeFrame': 'about 2 weeks after the randomization'}], 'secondaryOutcomes': [{'measure': 'Tolerability to the preparation (specific questionaire)', 'timeFrame': 'participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization', 'description': 'Tolerability will be assessed by using a questionnaire completed by the patients on arrival at the endoscopy unit before colonoscopy.\n\nThe patient acceptance/satisfaction to bowel preparation will be evaluated with the following question:\n\nWhat is the extent of your disturbance due to bowel preparation? Severe (the bowel preparation assumption was stopped and not completed)(score 3) Moderate (bowel preparation assumption was stopped several times because of side effects but finally completed)(score 2) Mild (bowel preparation was completed without pauses but with some mild side effects)(score 1) No side effects (score 0)'}, {'measure': 'safety (adverse event rate)', 'timeFrame': 'participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization', 'description': 'Safety will be evaluated through reported adverse events, physical examination and vital signs'}, {'measure': 'Lesion detection (type and lesion detection rate/patient)', 'timeFrame': 'about 2 weeks from the randomization', 'description': "Polyps will be categorized as non-neoplastic or neoplastic (ie, adenomatous). Adenoma will be diagnosed by pathological evaluation of retrieved polyps. Adenomas will be considered advanced when they will be ≥10 mm in size, with villous architecture, high-grade dysplasia or intramucosal carcinoma (pTis), or 3 or more adenomas will be found. Invasive cancer will be considered when malignant cells will be observed beyond the muscularis mucosa. Size of adenoma will be obtained from both the colonoscopist's assessment and the pathology report, with the larger measurement being used in the analyses. Site of adenoma will be recorded by the colonoscopist at the time of polypectomy. Lesions at or proximal to the splenic flexure will be termed right-sided lesions, those distal to the splenic flexure as left-sided, taking into account the type of colorectal surgical resection underwent by the patient. The adenoma detection rate will be defined as the proportion of colonoscopies with adenomas."}]}, 'conditionsModule': {'conditions': ['Intestinal Cancer']}, 'referencesModule': {'references': [{'pmid': '25910064', 'type': 'DERIVED', 'citation': 'Mussetto A, Frazzoni L, Paggi S, Dari S, Laterza L, Radaelli F, Hassan C, Triossi O, Fuccio L. Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial. Endoscopy. 2015 Oct;47(10):917-24. doi: 10.1055/s-0034-1391987. Epub 2015 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the most popular and safest bowel preparation regimens, however the 4-Liter volume is often poorly tolerated. More recently, it has been shown that the use of a low volume preparation (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Outpatients\n2. ≥18 yrs old,\n3. Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy\n\nExclusion Criteria:\n\n1. Inpatients\n2. Emergency Colonoscopy\n3. Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant\n4. Pregnant and/or lactating women'}, 'identificationModule': {'nctId': 'NCT01887158', 'acronym': 'PEGOP', 'briefTitle': 'Efficacy of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Santa Maria delle Croci'}, 'officialTitle': 'Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection. A Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'PEGOP0613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bisacodyl plus 2-Liter Polyethylene glycol', 'description': 'Patients randomized to the low-volume arm, will be invited to consume 2 sachets of Lovol-esse (Polyethylene glycol) in one liter of water at 8:00 PM the evening before the colonoscopy and 2 sachets in one liter of water 4 hours before their scheduled colonoscopy appointment; furthermore, the patients will be instructed to take three 5-mg tablets of bisacodyl the day before the procedure, at 5:00 PM.', 'interventionNames': ['Drug: Polyethylene glycol', 'Drug: Bisacodyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4-Liter Polyethylene glycol', 'description': 'Patients assigned to the high-volume arm will be invited to consume 2 envelopes of Selg-esse 1000 (polyethylene glycol) in 2 litres of water and drink the resulting solution in about 2-3 hours starting at 6:00 PM the evening before the colonoscopy; the day of the procedure, starting 5 hours before the procedure, the patients will be invited to complete the preparation with 2 others envelopes of Selg-esse 1000 (polyethylene glycol) dissolved in 2 litres of water.', 'interventionNames': ['Drug: Polyethylene glycol']}], 'interventions': [{'name': 'Polyethylene glycol', 'type': 'DRUG', 'armGroupLabels': ['4-Liter Polyethylene glycol', 'bisacodyl plus 2-Liter Polyethylene glycol']}, {'name': 'Bisacodyl', 'type': 'DRUG', 'armGroupLabels': ['bisacodyl plus 2-Liter Polyethylene glycol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48100', 'city': 'Ravenna', 'state': 'RA', 'country': 'Italy', 'facility': 'Alessandro Mussetto', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '48100', 'city': 'Ravenna', 'state': 'RA', 'country': 'Italy', 'facility': 'Ospedale S.Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Santa Maria delle Croci', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Alessandro Mussetto', 'investigatorAffiliation': 'Ospedale Santa Maria delle Croci'}}}}